Avascular Necrosis, Congenital Hip Dysplasia, Osteoarthritis of Hip
Conditions
Keywords
Arthroplasty, Replacement, Hip/methods, Hip Joint/physiopathology, Hip Joint/radiography, Hip Joint/surgery, Hip Prosthesis, Outcome Assessment (Health Care), Female, Male, Adult
Brief summary
The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.
Detailed description
The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.
Interventions
None listed
Sponsors
Corin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery. * Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis. * Patients who do not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral Stem Migration Radiographic Assessment | 2 weeks to end of study (approximately 2 years) post-operatively | Femoral stem migration (in millimeters (mm)) will be assessed using computer-assisted Einzel Bild Roentgen Analyze-Femoral Component Analysis (EBRA-FCA) software and radiographs taken at each interval. |
| Rate of Implant Failure | 2 weeks to end of study (approximately 2 years) post-operatively | The number of revisions will be recorded. |
| Radiographic Assessment of Wear in the Acetabular Components | 2 weeks to end of study (approximately 2 years) post-operatively | Anterior-posterior (AP) and lateral radiographs from each follow-up visit will be used to assess wear of the acetabular (hip) components. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | 2 weeks to end of study (approximately 2 years) post-operatively | A standardized set of questions and measurements to assess the function of the hip. It includes pain, function, range of motion (ROM), and absence of deformity. |
| UCLA (University of California, Los Angeles) Activity Level | 2 weeks to end of study (approximately 2 years) post-operatively | A subject-completed questionnaire which asks his/her current activity level. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 2 weeks to end of study (approximately 2 years) post-operatively | A standardized set of questions and measurements to assess the function of the hip. It includes pain, stiffness, and joint function. |
| SF (Short Form)-12 Questionnaire | 2 weeks to end of study (approximately 2 years) post-operatively | A subject-completed questionnaire with questions and he/she's health and well-being. |
Countries
Canada
Outcome results
None listed